Uploaded by 王浩

S9600 Operation manual

advertisement
S9600 Non-invasive Ventilator
Operation Manual
Nanjing Superstar Medical Equipment Co., Ltd.
Contents
1Safety item................................................................................................................................... 1
2Remarks of the picture, sign, term and abbreviation in the machine and manual........... 3
3 Statement....................................................................................................................................5
4 Operation scope.........................................................................................................................6
4.1 Intended use.................................................................................................................... 6
4.2 Contraindication...............................................................................................................6
4.3 Precautions...................................................................................................................... 6
5 EMC Information........................................................................................................................7
6 Main structure and operating principle.................................................................................12
6.1 Structure......................................................................................................................... 12
6.2 Operating principle........................................................................................................13
7Preparation................................................................................................................................ 14
7.1Installation of wetting cup..............................................................................................14
7.2Fill water in the wetting cup.......................................................................................... 14
7.3Installation of filtering cotton.........................................................................................15
7.4 Installation of SD card.................................................................................................. 15
7.5Connection of power supply......................................................................................... 16
7.6Connection of breathing tube and mask.....................................................................16
7.7Machine operating environment.................................................................................. 17
8 Check before operation.......................................................................................................... 18
8.1Check interval................................................................................................................. 18
8.2System check..................................................................................................................18
8.3Check of ventilation function........................................................................................ 18
9 Operation.................................................................................................................................. 19
9.1 Operation keys.............................................................................................................. 19
9.2Power-on......................................................................................................................... 19
9.3Ventilation mode selected.............................................................................................20
9.4 Parameters setting in ventilation mode..................................................................... 22
9.5 Alarm setting.................................................................................................................. 25
9.6 System setting............................................................................................................... 26
9.7 Operation of humidifier.................................................................................................27
9.8 Start-up/standby............................................................................................................ 27
9.9 Audio paused of alarm..................................................................................................27
9.10 Ventilation operation...................................................................................................28
9.11 On completion..............................................................................................................28
I
10 Alarm, warning and hint information...................................................................................29
11 Cleaning and maintenance.................................................................................................. 30
11.1 Clearance and disinfection of the contact part with patient..................................30
11.2 Cleaning of S9600...................................................................................................... 30
11.3 Cleaning of wetting cup..............................................................................................31
11.4 Cleaning of filtering sponge.......................................................................................31
12 Maintenance...........................................................................................................................32
12.1 Before everyday operation........................................................................................ 32
12.2 After operation of every patient.................................................................................32
12.3 Assemble after disinfection........................................................................................32
12.4 Every day or in case of needed................................................................................32
12.5 Every month or over 300 hours................................................................................ 32
12.6 Every year or operation over 4000 hours............................................................... 33
13 Disposal of wastes................................................................................................................ 34
13.1 Disposal of electronic and plastic parts...................................................................34
13.2 Scrap disposal of medical equipment......................................................................34
14 Alarm and handling............................................................................................................... 35
15 Troubleshooting..................................................................................................................... 38
16 Main technical specification.................................................................................................39
16.1 Environment conditions..............................................................................................39
16.2 Classification................................................................................................................39
16.3 Power supply............................................................................................................... 39
16.4 Electromagnetic Compatibility.................................................................................. 39
16.5 Ventilation mode..........................................................................................................40
16.6 Ventilation parameter adjustment.............................................................................40
16.7 Ventilation parameter Monitoring range.................................................................. 42
16.8 Alarm, hint and protection..........................................................................................44
16.9 Noise.............................................................................................................................44
17 Move, storage and transportation.......................................................................................45
17.1 Move............................................................................................................................. 45
17.2 Storage......................................................................................................................... 45
17.3 Transportation..............................................................................................................45
18 After-sales service commitments........................................................................................46
II
1Safety item
!
△
Note:

This machine is applied to adult patients only, not for life support.

Non-invasive Ventilator is subject to the possibility of repetitive breathing. To reduce this
possibility, pay attention to the following:


Only breathing tubes and facemasks provided by our company or recommended by a
physician shall be used.

Don’t block the expiratory port.

When this machine is not turned on, avoid wearing the face mask and headband for a long
time.
In case of any of the following, do not use this machine anymore and contact our company:

Excessive temperature of air output from this machine or peculiar smell of this air;

This machine generates abnormal or shrill noise;

This machine falls from high place, water enters this machine, or machine casing is
damaged.

To prevent electric shock, please disconnect the power supply before cleaning this machine;
never dip this machine in any liquid.
!
△
Warning:

This manual serves as a reference. The instructions in this manual are not intended to
supersede the instructions of your care giver.

You should read and understand this entire manual before using this machine.

This Non-invasive Ventilator shall be used by physician or under physician’s guidance. Do not
use this machine before doctor helps you to select required treatment pressure and parameters.

Never tilt or put this machine complete with the humidifier upside-down, to prevent back flow of
liquid inside the humidifier into this machine.

In case user needs to carry this machine, first empty water in the humidifier; never carry it with
water inside.

Do not use the machine in ambient temperatures above 35℃. If the machine is used at ambient
temperatures above 35℃, the temperature of the breathing air may exceed 41℃, which could
cause thermal irritation or injury to your airway.

Never use this machine if the air contains inflammable, explosive, or anesthetic gas.

Do not operate the machine in direct sunlight or near a heating appliance because these
conditions can increase the temperature of the air coming out of the machine.

Do not disassemble the machine without the authorization from our company. If the user needs
to repair, this machine can only be operated by special qualified personnel after training.

Never use the antistatic threaded pipe and facemask. It may be cause inflammation if use this
1
kind of threaded pipe and face mask near the high frequency electric operation equipments.

Use of mobile phone or other RF radiating equipment near this machine may cause unexpected
problem or abnormity. In case RF radiating source exists nearby, machine operating status shall
be monitored.

Use of other electrical equipment on or near this system may cause interference. Before this
machine is used for a patient, check if this machine is operating normally according to your
configuration.

Same or similar equipment used in any separate area that adopts different alarm settings may
cause potential hazard.

Use of medical equipment with similar or seemingly same appearance but different software
and internal functions (including default operations upon alarm and other alarm characteristics)
may cause disorder among operators.

This machine is subject to the possibility of re-inhalation of exhaled carbon dioxide. Under
normal status or single fault status, face mask (or connector) with air vent or exhaust machine
shall be used matching this machine, to reduce re-inhalation of exhaled carbon dioxide to a
minimum.

Under normal operating status of this machine, maximum pressure is limited to 35cmH2O.
Under single fault condition, maximum pressure is limited to 40cmH2O.

In case environment/power supply (power supply and gas supply) exceeds the following limit, if
one parameter is changed but other parameters are in normal range, operation of this machine
can continue. Parameter may exceed its limit but shall not cause safety hazard to patient or
operator.
Ambient temperature:5℃-40℃;
Relative humidity :10%-95%;
Atmospheric pressure :700mbar-1060mbar;
AC power supply voltage:-15% - +10% of rated voltage
DC power supply voltage:-15% - +25% of rated voltage

In case of interruption of power supply during normal operation, machine operation will stop.
After the power supply is restored, the operation manual can be followed to store normal
machine operation.

Under normal operating status, maximum flow of this breathing machine under operating
pressure of 8cmH2O, 16cmH2O, or 25cmH2O is 50L/min, 100L/min, or 145L/min respectively.
2
2Remarks of the picture, sign, term and
abbreviation in the machine and manual
“
” indicates ‘Follow instructions for use’.
“
warning ” and “
note” indicate if the instruction is not followed, there will be some
emergencies, please read and keep to all the “ warning” and “note” items.
Warning: indicates that if the instruction is not followed, the machine may be damaged, you and your
patient may be injured.
Note: indicates that if the instruction is not followed , the machine may be damaged, and can not
work normally.
Hint:indicate you should pay attention to the explanation.
In the machine and manual, the picture, sign, term and abbreviation are used to replace the
language remarks. However, all these picture, sign, term and abbreviation are not all involved in the
machine and manual.
Table 1
Remarks of the picture, sign, term and abbreviation in the machine and manual
Picture, sign, term and
abbreviation
Explanation
Follow instructions for use
Type BF applied part
Class Ⅱ
Alarm audio paused
Alarm audio closed
Heat level of humidifier
·
System settings
start/paused
The device, accessories and the packaging have to be disposed
of waste correctly at the end of the usage. Please follow Local
Ordinances or Regulations for disposal.
cmH2O
Centimeters of water
3
Picture, sign, term and
abbreviation
Explanation
bpm
Breath per minute
mL
Milliliter
s
Second (Unit for time)
L/min
Liter per minute
CPAP
Continuous Positive Airway Pressure
IPAP
Inspiratory Positive Airway Pressure
EPAP
Expiratory Positive Airway Pressure
AUTO
Automatic pressure titration function.
AVAPS
Average volume assures pressure support
S/T
Spontaneous/Time control ventilation
Para Set
Parameter Setting
Tramp
Ramp Time
VT
Tidal Volume
Para Set
Parameter Setting
Tramp
Ramp Time
Freq
Frequency
Tinsp
Inspiratory Time
Trise
Rise Time
Vitr
Inspiratory Trigger
Vetr
Expiratory Trigger
Pup
Pressure upper limit
4
Picture, sign, term and
abbreviation
Explanation
MVlow
Minute Volume low limit
Fup
Frequency upper limit
FLow
Frequency low limit
Discon
Disconnect
Pup!!
Ppeak High alarm
MV Low!!
Minute Volume Low alarm
Fup!!
Frequency High alarm
FLow!!
Frequency low alarm
3 Statement
S9600 Non-invasive Ventilator features the following monitoring, alarm, and protection devices:
—Breathing pressure measuring and control device
—Frequency measuring and control device
—Inspiratory time measuring and control device
—VT and MV measuring
—Pressure upper limit alarm and limiting device
—MV low limit alarm
—Frequency upper and low limit alarm
—Disconnect alarm
—Apnea alarm
5
4 Operation scope
4.1 Intended use
S9600 is intended to provide non-invasive ventilation in adult patients for the treatment of obstructive
sleep apnea and not for life support. This machine may be used in the hospital or home.
4.2 Contraindication
Use of this product is prohibited in case of the following:

Obstruction of upper respiratory tract

High risk of erroneous inhalation, incapability of removal of secretion from oral pharynx and
respiratory tract, or poor protection of respiratory tract

Trauma, burn, or anomaly of cervical part or face

Pneumothorax not drained1

Recent operation in face, cervical part, oral cavity, pharynx cavity, esophagus, or stomach1

Obvious noncooperation or extreme stillness1

Excessive air passage secretion or obstruction in phlegm discharge1
Note: 1 indicates relative contraindication. For such patients, advantages and disadvantages of
trauma-free positive pressure ventilation shall be very carefully balanced, to decide use of
trauma-free positive pressure ventilation (1mmHg=0.133kPa) or not.
4.3 Precautions
Immediately report any unusual chest discomfort, shortness of breath, or severe headache to your
physician or dealer. If skin irritation or breakdown develops from the mask, refer to the mask
instructions for appropriate action.
The following are potential side effects of noninvasive positive pressure therapy:
• ear discomfort
• conjunctivitis
• skin abrasions due to noninvasive interfaces
• gastric distention (aerophagia)
6
5 EMC Information
Important Notice

The S9600 Non-invasive Ventilator meets the requirement of electromagnetic compatibility in
IEC60601-1-2.

The user needs to install and use according to electromagnetism compatibility information
which is attached with it.

Portable and mobile RF communication devices may influence S9600 performance, so S9600
should be kept away from them during using.

Guidance and manufacturer’s declaration stated in the appendix.
Warning:

S9600 Non-invasive Ventilator should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, S9600 should be observed to verify normal
operation in the configuration in which it will be used.

Class A equipment is intended for use in an industrial environment. S9600 may be potential
difficulties in ensuring electromagnetic compatibility in other environments, due to conducted as
well as radiated disturbances.
7
Table 1
Guidance and manufacturer’s declaration –electromagnetic emissions
The S9600 Non-invasive Ventilator is intended for use in the electromagnetic environment
specified below. The customer or the user of the SECP-II should assure that it is used in such an
environment.
Emissions test
RF emissions
CISPR 11
Compliance
Electromagnetic environment - guidance
Group 1
The S9600 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Complies
The S9600 is suitable for use in all establishments
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
8
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
The S9600 Non-invasive Ventilator is intended for use in the electromagnetic environment specified
below.
The customer or the user of the S9600 should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Electrostatic
discharge (ESD)
±6 kV contact
±8 kV air
Compliance level
Electromagnetic environment –
guidance
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±2 kV for power
supply lines
Mains power quality should be that of a
typical
commercial
or
hospital
environment.
Surge
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be that of a
typical
commercial
or
hospital
environment.
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Mains power quality should be that of a
typical
commercial
or
hospital
environment. If the user of the S9600
requires continued operation during
power mains interruptions, it is
recommended that the S9600 be
powered from an uninterruptible power
supply or a battery.
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
3 A/m
3 A/m
magnetic field
IEC 61000-4-8
NOTE
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
UT is the a.c. mains voltage prior to application of the test level.
9
Table 3
Guidance and manufacture’s declaration – electromagnetic immunity
The S9600 Non-invasive Ventilator is intended for use in the electromagnetic environment specified
below. The customer or the user of S9600 should assure that it is used in such an environment.
IEC 60601 test
Complianc
Immunity test
Electromagnetic environment - guidance
level
e level
Portable and mobile RF communications
equipment should be used no closer to any
part of the S9600,, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms
3V
d  1.2 P
IEC 61000-4-6 150 kHz to 80 MHz
3 V/m
Radiated RF
IEC 61000-4-3
3 V/m
d  1.2 P 80 MHz to 800 MHz
d  2.3 P 800 MHz to 2.5 GHz
80 MHz to 2.5 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya should be less than the compliance
level in each frequency rangeb.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE
These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the S9600 is used exceeds the applicable RF compliance
level above, the S9600 Non-invasive Ventilator should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the S9600.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
10
Table 4
Recommended separation distances between
portable and mobile RF communications equipment and the S9600 Non-invasive Ventilator
The S9600 Non-invasive Ventilator is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the S9600 Non-invasive
Ventilator can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the S9600 Non-invasive
Ventilator as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 kHz ~ 80 MHz
d = 1 .2 P
80 MHz ~ 800 MHz
d =1,2
800 MHz~ 2,5 GHz
d = 2,3
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
11
6 Main structure and operating principle
Non-invasive Ventilator is comprised of main machine, humidifier, breathing tube and facemask.
6.1 Structure
1 Key (used to modify machine working parameters and control machine operating status)
2 Display screen (display system settings, monitoring parameters, wave form, alarm, etc)
3 Inspiratory port (connected to 1.8m breathing tube); display of humidifier grade
4 Wetting cup
5 DC power supply interface (connected to 24V DC power supply cable)
6 Filtering cotton and air inlet
7 label
8 Water box cover
Fig.1 Whole machine outline
Note: The male 22mm conical connector complied with ISO 5356-1 should be used in inspiratory
port (patient port).
12
6.2 Operating principle
See Fig.2 for operating principle block diagram.
Fig.2 Operating principle block diagram
The fan adjusts air to required pressure and delivers it to patient via the humidifier.
The control board carries out processing according to parameters set on the panel and air passage
pressure and flow data acquired by sensors, and displays control values and monitored values on
the panel.
The control board also generates audio and video alarm when a monitored breathing parameter
exceeds the alarm setting according to alarm parameters set on the panel.
13
7Preparation
7.1Installation of wetting cup
Align wetting cup mounting groove to corresponding fixing groove on main part of this machine.
Lightly push the cup to the bottom and sway left and right to check for looseness and ensure proper
connection, as shown in the figure below:
7.2Fill water in the wetting cup

As shown in 7.1, take out the wetting cup in the reserve direction;
 Use a water sup to add suitable amount of pure water or running water into the wetting cup; as
shown below:
!
△
Notice
1) When the water box is placed horizontally, its filled volume shall be not more than 300mL
and its water level shall be parallel with the maximum scale. If filled volume is too large and
the device is placed at a slant angle, water will enter user’s trachea or body which will
injure the patients and damage the device.
2) When water volume is less than the minimum scale, please add pure water or tap water
appropriately to avoid damaging the device.
14
7.3Installation of filtering cotton
As shown in Fig.1, pull up the gas inlet (6) by hand. Lightly pinch two sides of clean filtering cotton to
place it inside the air inlet. Pay attention to allow good contact between filtering cotton and air inlet.
To prevent blocking of air inlet, the filtering cotton must not be deformed.
7.4 Installation of SD card
Open the silicone cover marked Micro-SD and insert SD card into the hole, then put silicone cover
back, as shown in follow figure:
Note:
1)When installing SD card, its metal surface shall be put upward, as shown in right figure;
2)Open the silicone cover from one end of word SD, because another end is connected with the
machine.
15
7.5Connection of power supply
Insert AC plug of the power supply adapter into the AC socket and insert the DC plug of the DC
power supply adapter into the DC power interface at a side of the main part of the machine. Refer to
the figure below:
7.6Connection of breathing tube and mask
!
△
Note:
1)The breathing tube should meet the requirement of Standard of ISO 5367;
2)The mask should meet the requirement of Standard of ISO 17510-2;
3)Refer to operation manual for mask’s operation.
As shown in below Fig:
1 Non-invasive Ventilator
2 breathing tube
3 mask
Note: During operation of the machine, do not block the air leakage hole. If total face mask is used,
such mask must have safety valve, to prevent suffocation of patient in case of interruption of power
supply.
16
7.7Machine operating environment
S9600 Non-invasive Ventilator shall be placed on a solid and stable desktop, away from heating and
cooling equipment (air conditioning and electric blanket etc.), to prevent blocking of machine air inlet
by cotton wool, quilt, blanket, or other object. To ensure normal operation of the machine, free air
flow shall be maintained around the machine.
17
8 Check before operation
!
△
Warning:
1) In order to ensure the excellent performance in operation, connection, safety feature and alarm
function must be checked before operation.
2) Do not use machine with problem. If there is alarm from the machine, do not use it, for machine
may be damaged, or the patient may be injured.
8.1Check interval
Please make check before operation under the following situation:

Before usage of every patient;

After maintenance and disinfection;

After repairing.
8.2System check

Check all connection part is stable and correct;

Check the breathing circuit pipe is in good condition and are connected stable and correct;

The connection of the power lines are stable.
8.3Check of ventilation function

Block the connection point between the breathing tube and the mask. Switch on the machine.

After the machine is switched on, in default mode, this machine shall supply air according to
default parameters and no abnormity shall be displayed.
18
9 Operation
9.1 Operation keys
1 Standby/start key
2 System setting key
3 Adjusting shuttle
Fig 3 Panel operation keys
9.2Power-on

Connect the power supply.

Enter starting up interface (First starting up and default S/T Mode), see Fig. 3, rotate adjusting
shuttle (item 3 in Fig. 3) to enter the second interface, see Fig.4.

When AVAPS is off, the display screen will not display maximum and minimum value of IPAP,
the second interface will not display the setting value of VT, see Fig.5.
Fig 4 First starting up interface
19
Fig 5 AVAPS is off—starting up interface
Note: The next starting up interface works for the last run.
9.3Ventilation mode selected

First press keys “
” and “
” (item1 and 2 in Fig.3) at the same time. Then insert power
supply. The default interface will be displayed, as shown in Fig.4, or the last operation interface.

Press key “
” (item 2 in Fig.3), parameter set interface will be displayed;

Rotate the shuttle knob (item 3 in Fig.3) to select the needed mode. Press the shuttle knob (3 in
Fig.3) so that the selected mode is displayed in reverse color. See Fig.11, Fig.12, Fig.13, Fig.14
and Fig.15.

Rotate the shuttle knob (3 in Fig.3) to “OK”, press it to exit. The machine will operate under the
selected mode.

See Fig.6, Fig.7, Fig.8, Fig.9 and Fig.10 for other ventilation modes (Fig.6, Fig.7 , Fig.8, Fig.9
and Fig.10 before closing AVAPS and after closing AVAPS).
Fig. 6 Interface of S/T Mode
20
Fig. 7 Interface of S Mode
Fig. 8 Interface of PC Mode
Fig. 9 Interface of T Mode
Fig.10 Interface of CPAP Mode
21
9.4 Parameters setting in ventilation mode

Press the key “
” (item 2 in Fig.3), parameter setting interface will be displayed, as shown
in Fig. 11, Fig. 12, Fig. 13, Fig. 14 and Fig. 15.

Rotate the shuttle knob (item 3 in Fig.3) to select the needed setting option. Press the shuttle
knob (item 3 in Fig.3) so that the selected setting option is displayed in reverse color.

Rotate the “Shuttle adjustment/confirm” knob (3 in Fig.3) to achieve required value of the
parameter: clockwise to increase the parameter value and counterclockwise to decrease the
parameter value.

Press the shuttle knob (item 3 in Fig.3) to confirm setting of this parameter.

To adjust the next parameter, repeat steps described earlier.

Rotate the shuttle knob (item 3 in Fig.3) to “OK”. Confirm settings and exit. The machine will run
according to adjusted ventilation parameters.
Fig.11 Parameter setting interface in S/T mode
When AVAPS is on, the following parameters can be adjusted: IPAPmax, IPAPmin, EPAP,
Tramp, Freq, Tinsp, Vitr, Vetr and VT.
22
Fig.12 Parameter setting interface in T mode
When AVAPS is on, the following parameters can be adjusted:IPAPmax, IPAPmin, EPAP,
Tramp, Freq, Tinsp and VT.
Fig.13 Parameter setting interface in S mode
When AVAPS is on, the following parameters can be adjusted: IPAPmax, IPAPmin, EPAP,
Tramp, Vitr, Vetr , Auto and VT
23
Fig.14 Parameter setting interface in CPAP mode
When AVAPS is on, the following parameters can be adjusted: IPAPmax, IPAPmin, EPAP,
Tramp, Tinsp, Vetr and VT.
Fig.15 Parameter setting interface in CPAP mode
Note: During parameter setting, the machine will operate according to ventilation and alarm
parameters of the last mode.
Hint:
1) Selected item will be displayed in reverse color; same below.
2) When AVAPS is on, IPAP has maximum and minimum value two parameters.
3) When reaching maximum value or minimum value of adjustment range, adjustment of this
machine will stop automatically.
24
9.5 Alarm setting

Press the key “
” (item 2 in Fig.3) twice; Alarm setting interface will be displayed; as
shown in Fig.16.

Rotate the shuttle knob (item 3 in Fig.3) to select the alarm parameter to be set; press the
shuttle knob (item 3 in Fig.3), so that selected alarm parameter is displayed in reverse color.

Rotate shuttle knob (item 3 in Fig.3) to achieve required value of the parameter: clockwise to
increase the parameter value and counterclockwise to decrease the parameter value.

Press the shuttle knob (item 3 in Fig.3) to confirm setting of this parameter.

To adjust the next parameter, repeat steps described earlier.

Rotate the shuttle knob (item 3 in Fig.3) to “OK”. Confirm settings and exit. The machine will run
according to adjusted alarm parameters.
Fig.16 Alarm setting
Hint:
1) When adjusting alarm parameters, if upper or lower limit is exceeded, adjustment will be limited
automatically.
2) Audio alarm can be closed, visual alarm can not be closed.
25
9.6 System setting

Press the key “
” (item 2 in Fig.3) three times, system setting interface will be displayed,
as shown in Fig.17.

Rotate the shuttle knob (item 3 in Fig.3) to select the system parameter to be set, press the
shuttle knob (item 3 in Fig.3) so that selected system parameter is displayed in reverse color.

Rotate “Shuttle adjustment/confirm” knob (item 3 in Fig.3) to achieve required value of the
parameter: clockwise to increase the parameter value and counterclockwise to decrease the
parameter value.

Press the shuttle knob (item 3 in Fig.3) to confirm setting of this parameter.

To adjust the next parameter, repeat steps described earlier.

Rotate the shuttle knob (item 3 in Fig.3) to “OK”. Confirm settings and exit. The machine will run
according to adjusted alarm parameters.
Fig.17 System setting
Hint:
1) When adjusting alarm parameters, if upper or lower limit is exceeded, adjustment will be limited
automatically.
2) When adjusting time, year and month and day and time are set respectively.
3) Runtime and SN and version can not be adjusted.
4) Pressure unit switch, its corresponding setting and monitoring value switch with it.
26
9.7 Operation of humidifier

In working interface, press shuttle key to select step position number in Fig.4.

Rotate shuttle knob (item 3 in Fig.3) to achieve required value of the parameter: clockwise to
increase the parameter value and counterclockwise to decrease the parameter value.

Press shuttle key (item3 in Fig.3) to confirm setting of this parameter.
Hint:
1)
To modify machine parameters, carry out operations 9.3, 9.4, 9.5 and 9.6. After setting,
disconnect power supply; the system will automatically save setting parameters. Next time the
machine is turned on. It will run according to parameters set last time.
2)
Parameters can only be modified by first pressing keys “
” and “
” (item 1 and 2 in Fig.3)
at the same time and then connect power supply.
9.8 Start-up/standby
Press the “
” key, gas supply is active; Press it again, gas supply is stopped.
9.9 Audio paused of alarm
When alarm occurs, if press the shuttle knob for 2s, alarm sound will be paused, but visual signal
still exist and the symbol “
” will be displayed on the screen until the alarm condition disappears.
27
9.10 Ventilation operation

Connect power supply;

Connect the breathing tube and mask;

Select ventilation mode;

Set parameters;

Set alarm parameters;

Start Ventilation.
!
△
Warning:
1)
Read this manual carefully before operation, use the machine strictly according to the
instruction.
During use of this machine, suitable inspiration parameters and alarm parameters shall be set
according to patient conditions.
During use of this machine, arrange breathing tubeline and cables with care to avoid twinning
and patient suffocation.
During use of this machine, never move or cover this machine at will; maintenance during use is
not permitted.
Alarm during use shall be timely handled. First ensure patient safety, and then carry out
troubleshooting or necessary repair.
Dripping or splash of liquid into this machine may cause damage or electric shock.
2)
3)
4)
5)
6)
9.11 On completion

Press the “
” key, turn off the system;

Disconnect the breathing tube and mask;

Pull out the power adapter from the main machine and AC power supply socket in the wall.
△
! Warning:
Before disconnecting the wetting unit from main part of this machine, take out the water box to
prevent back-filling of liquid into the machine, damaging the machine.
28
10 Alarm, warning and hint information
△
! Warning:
If there is alarm during operation, safeguard the patient firstly, then check immediately to fix the
fault.
Please refer to below table of the alarm and warning information.
Alarm and warning information
Alarm and warning information
MV low!!
Cause
MV is less than the set low limit
Pup !!
Ppeak exceeds the set upper limit
Fup!!
Frequency exceeds the set upper limit
Flow!!
Frequency is less than the set low limit
Apnea!!
No spontaneous breathing lasting for 8s to 12s.
Discon!!
Disconnect the breathing tube for 16s.
Vt low !!
Vt is less than the set low limit
A alarm display when alarm audio is closed
29
11 Cleaning and maintenance
11.1 Clearance and disinfection of the contact part with
patient
Clearance and disinfection before first use
Use cloth dipped in water or mild detergent to clean front panel and casing exterior as required.
Use alkaline disinfection method to disinfect breathing tube (threaded pipe). Disinfection
temperature shall not exceed 75℃ or 170℉.
Refer to the operation manual of mask for mask’s Clearance and disinfection.
Clearance and disinfection of reusable part
The reusable parts of this machine include breathing tube and mask.
Process for clearance and disinfection after operation:

Use alkaline disinfection method to disinfect breathing tubes
temperature shall not exceed 75℃ or 170℉.

Refer to the operation manual of mask for mask.
(threaded pipes). Disinfection
Using times for the reusable part
Under normal condition and no damage:

Breathing tubeline can be used (after disinfection) for 50 times or for 6 months.

Refer to the operation manual of mask for mask.
11.2 Cleaning of S9600
Before cleaning or conventional maintenance, ensure S9600 in non-operating status and disconnect
S9600 from its power supply. Before cleaning, take down breathing tube, face mask, and wetting
cup. Use warm water and mild detergent solution to lightly clean the piping that can be used
repeatedly. Thoroughly wash the piping and dry it in the air.
Use cloth dipped in water or mild detergent to clean front panel and casing exterior as required.
Before insertion of power supply cable, thoroughly dry S9600.
Precautions for cleaning:
Do not use alcohol, acetone, chloride, or abrasive cleaning agent for cleaning.
Do not use solution of temperature higher than 50°C (122°F) for cleaning.
30
11.3 Cleaning of wetting cup
In case your device is not configured with wetting unit, it is not necessary to read the following
prompts:

Cut off power supply to the Non-invasive Ventilator.

Remove ventilation pipeline, open side cover of the wetting unit, and remove wetting cup.

Use detergent or washing solution (of temperature not exceeding 65°C/150°F) to clean the
wetting cup.
11.4 Cleaning of filtering sponge

The filtering sponge is placed in the filtering box at a side of the device and can be taken out
directly.

Use neutral cleaning agent for cleaning. After cleaning, place it in a cool place away from
sunshine for drying. Do not knead the sponge during cleaning.

The filtering sponge shall be replaced after one month of use.

Before use of this machine, it is necessary to install dried filtering sponge.
! Note:
△
1)
Do not install wet filtering sponge in this Non-invasive Ventilator; otherwise this machine may be
damaged.
2)
Failure to replace filtering sponge in time may affect your health.
3)
In case of relatively serious external dusting or smoke, filtering sponge replacement interval
shall be shortened according to particular conditions.
31
12 Maintenance
!
△
Warning:
1.
Do not use machine with any problem.
2.
The machine can only be repaired by authorized personnel. If the user needs to repair,,This
machine can only be operated by special qualified personnel after training. When necessary,
our company can provide the necessary information
3.
Only authorized and qualified personnel can do calibration of the machine, or special qualified
personnel after training.
!
△
Note:
After maintenance, check the machine according to the Chapter of “Check before operation”.
12.1 Before everyday operation
Before first operation, clean the surface of the machine everyday.
12.2 After operation of every patient
Do disinfection after operation of every patient.
12.3 Assemble after disinfection
Check the machine according to the chapter of “Check before operation” after disinfection. If any
part is broken, replace or repair it immediately.
12.4 Every day or in case of needed
Check the machine according to the chapter of “Check before operation”. If any part is broken,
replace or repair it immediately.
12.5 Every month or over 300 hours
Check the machine according to the chapter of “Check before operation”. If any part is broken,
replace or repair it immediately.
32
12.6 Every year or operation over 4000 hours

Maintain and check the machine completely;

Replace the gasket;

Check and calibrate:
— Monitoring the value of flow;
— Monitoring the value of pressure;
33
13 Disposal of wastes
13.1 Disposal of electronic and plastic parts
!
△
Warning
Do not dispose of electronic and plastic parts replaced from maintenance at option, to avoid
environmental pollution.
Dispose of electronic and plastic parts replaced from maintenance at option will cause environmental
pollution. Local environmental protection laws shall be executed.
13.2 Scrap disposal of medical equipment
When service life is over, do not dispose it as household waste, and dispose it separately.

Please abide the local environment law for waste disposal.

Please refer to Environmental Protection Agency or government or waste disposal company for
waste disposal.
34
14 Alarm and handling

If there is alarm during the operation, safeguard the patient firstly, then check immediately to fix
the fault.

Operator’s position:
Visual alarm: operator at any position 1m from the display screen and within angle of 30° with
horizontal plane of screen center.
Audible alarm: operate at any position 1m from the machine.

Before and after interruption of power supply, default alarm value will not change.

Default alarm value can only be accessed for modification (including in storage) using a special
tool.

Volume of audible alarm: medium priority: 68dB
Alarm priority:
Priority
Alarm way
Continuous and repeated three tones and with 20
second interval
Medium

Alarm information:
Alarm
MV Low!!
Pup!!
Fup!!
Priority
Medium
Medium
Medium
Setting range
0L~15L/min
20cmH2O~35cmH2O
1bpm~99bpm
35
Default
value
Alarming way
2.0 L/min
When the monitoring value
less than MV low limit of
alarm, there will be audible
alarm and visual alarm.
30 cmH2O
When the monitoring value
over the upper limit of Ppeak,
there will be audible alarm
and visual alarm.
40 bpm
When the monitoring value
over the upper limit, there will
be audible alarm and visual
alarm.
Alarm
F Low!!
Apnea!!
Discon!!
Vt low!!

Priority
Medium
Medium
Medium
Medium
Setting range
1bpm~60bpm
ON/OFF
ON/OFF
ON/OFF
Default
value
Alarming way
1 bpm
When the monitoring value
less than the low limit, there
will be audible alarm and
visual alarm.
OFF
No spontaneous breathing
lasting for 8s ~ 12s, there
should be audible alarm and
visual alarm.
OFF
Disconnect breathing tube
lasting for 16s, there should
be audible alarm and visual
alarm.
OFF
When inspiratory pressure
value over its upper limit, tidal
volume do not reach its set
value, there will be audible
alarm and visual alarm.
Cause of alarm and solution of alarm:
Alarm
Cause
Solution of alarm
Disconnect
alarm
In case serious air leakage is detected upon startup Check for correct connection of
of this machine, corresponding type of alarm will pipeline with face mask;
flash in the alarm box, with audible alarm.
Press the audio paused key.
Apnea
alarm
Under S/T and S mode, Upon startup of this Check patient ventilation status;
machine, if breathing is not detected within set
Check
the
connection
of
alarm time of 8s~12s, corresponding type of alarm
breathing tube and mask;
will flash in the alarm box, with audible alarm.
Press the audio paused key.
MV alarm
Upon startup of this machine, if detected MV is Check patient ventilation status;
higher than a set threshold, corresponding type of
Check if the set threshold of MV
alarm will flash in the alarm box, with audible alarm.
is too low;
Check
the
connection
breathing tube and mask;
36
of
Press the audio paused key.
High
Frequency
alarm
Upon startup of this machine, if detected breath Check patient ventilation status;
frequency is higher than a set threshold,
Check if the set threshold of Fup
corresponding type of alarm will flash in the alarm
is too low;
box, with audible alarm.
Press the audio paused key.
Low
Frequency
alarm
Upon startup of this machine, if detected breath Check patient ventilation status;
frequency is lower than a set threshold,
Check if the set threshold of Flow
corresponding type of alarm will flash in the alarm
is too high;
box, with audible alarm.
Press the audio paused key.
High
Ppeap
alarm
Upon startup of this machine, if detected patient Check patient ventilation status;
airway pressure is higher than a set threshold,
Check if Pup alarm threshold is
corresponding type of alarm will flash in the alarm
too low;
box, with audible alarm.
Press the audio paused key.
Low Vt
alarm
Check patient ventilation status;
Upon startup of this machine and inspiratory
pressure is more than maximum inspiratory Check if maximum inspiratory
pressure,
if detected Vt is lower than its set pressure value and Vt set value
value, corresponding type of alarm will flash in the are suitable;
alarm box, with audible alarm.
Press the audio paused key.
37
15 Troubleshooting
Fault
Cause analysis
Method of correction
The machine can
only generate low
pressure
Blocking of filtering sponge or
air outlet; or pressure delay is
set in CPAP mode.
Clean or replace filtering sponge, clean air
outlet, if necessary, cancel the delay or set
the delay again
Too high noise
Ventilation pipeline not or
incorrectly connected; air
leakage in face mask or
breathing tubeline; connection
between wetting cup and the
breathing machine not
properly sealed
Check for correct pipeline connection;
After startup, the
system prompts fault
in fan.
Fault in the fan or connection
problem
Connect with sales service center of our
company.
After startup, the
machine does not
run.
Power supply plug not
properly connected;
Check for correct connection of the
breathing machine with its power supply
(first turn off the AC power supply); check
availability of indoor power, e.g. by light;
Damage inside power supply
Check for correct breathing tubeline;
Check for normal connection between the
wetting cup and the main part of the
breathing machine.
Connect with sales service center of our
company.
The fan runs
normally, but the
pressure obviously
does not conform to
set pressure
Output air from the
machine is relatively
hot.
Air flow output by the
machine is too small.
Water present in the
face mask
Incorrect connection of
breathing tubeline;
Air leakage in face mask or
breathing tubeline.
Too dirty filtering sponge;
Blocked air inlet;
Poor air circulation due to the
machine too near wall,
curtain, or other object.
Blocking of air inlet;
The machine is in delayed
pressure rise.
Condensate in face mask due
to low room temperature.
38
Check if connection is correct and stable;
Connect with sales service center of our
company.
Clean or replace filtering sponge;
Check air inlet;
20cm Move machine to a place with free air
circulation, at least 20cm from wall, curtain,
or other object
Check gas inlet;
Shorten ramp time.
Lower temperature of humidifier or increase
ambient temperature.
16 Main technical specification
16.1 Environment conditions


Working environment:
Ambient temperature
5 ℃~ 35 ℃
Relative humidity
15 %~ 95 %
Atmospheric pressure
830 hPa~1060 hPa
Storage environment:
Ambient temperature
-20 ℃~+60 ℃
Relative humidity
15 %~ 95 %
Atmospheric pressure
500 hPa~1060 hPa
16.2 Classification
Classified according to IEC60601-1,S9600 belong to:

ClassⅡequipment;

Type BF equipment;

IPX1;

Common equipment;

Continuous operation;

This machine can be disinfected.
16.3 Power supply

Power supply: DC 24 V(-15 % ~ +25 %), 2.5 A;

Power adapter: AC input 100 V -240 V~, Frequency 50HZ /60 HZ
DC output 24 V,2.5 A
16.4 Electromagnetic Compatibility
!
△
Warning:
1)
Cell phone and other radiation equipment used near the machine will cause unexpected
problem to Non-invasive Ventilators. If there is radio frequency radiation source nearby, working
status of the equipment should be monitored.
2)
The other equipment added to or near Non-invasive Ventilators will lead to disturbance to the
machine. Before used to the patient, check if the machine works normally under the set values.
39
16.5 Ventilation mode
——CPAP
——Spontaneous Breath (S)
——Time control (T)
——S/T
——PC
16.6 Ventilation parameter adjustment

AVPAS
——Adjusting range: ON/OFF
——Step: 1

Tidal volume
——Adjusting range:200mL~1500mL
——Step: 10 mL
——Allowable error:>100 mL,± 20 %;
≤100 mL,± 20 mL

Frequency
——Adjusting range:3 bpm~ 40 bpm
——Step:1 bpm
——Allowable error:±15 %

Inspiratory time
——Adjusting range:0.0 s ~ 3.0 s
——Step: 0.1 s
——Allowable error:±15 % or ± 0.3 s, whichever is the greater

Pressure limit
——Adjusting range:20cmH2O ~ 35 cmH2O
——Step: 0.5cmH2O

IPAP
——Adjusting range:4 cmH2O ~ 30 cmH2O
——Step: 0.5cmH2O
——Allowable error:±(2 % of full scale+8% of actual reading)

IPAPMAX
——Adjusting range:4 cmH2O ~ 30 cmH2O
40
——Step: 0.5 cmH2O
——Allowable error:±(2 % of full scale+8 % of actual reading)

IPAPMIN
——Adjusting range:4 cmH2O ~ 30 cmH2O
——Step: 0.5cmH2O
——Allowable error:±(2 % of full scale+8 % of actual reading)

EPAP
——Adjusting range:4 cmH2O ~ 25 cmH2O
——Step: 0.5cmH2O
——Allowable error:±(2 % of full scale+8 % of actual reading)

CPAP
——Adjusting range:4 cmH2O ~ 20 cmH2O
——Step: 0.5cmH2O
——Allowable error:±(2 % of full scale+8 % of actual reading)

Ramp time
——Adjusting range:0 min ~ 60 min
——Step: 1 min
——Allowable error:± 15 %

Rise time
——Adjusting range: Auto adjusting,0.1 s~ 0.6 s
——Step: 0.1 s
——Allowable error:± 30%

Inspiratory trigger
——Adjusting range: Auto adjusting,1~3
——Step: 1

Expiratory trigger
——Adjusting range: Auto adjusting,1~3
——Increment:1

Flex
——Adjusting range:Off,1~3
——Step: 1

Humidifier
——Adjusting range:0~5
41
——Step: 1

Automatic function
——Adjusting range: OFF、ON
——Step: 1
16.7 Ventilation parameter Monitoring range

The following are monitoring parameters under the environment of body temperature and
pressure-saturated.

Fig display:
Monitoring
parameter
Range
Resolution
Frequency
0 bpm ~ 100 bpm
1 bpm
VT
0 L~2000mL
1 mL
Accuracy
±15 %
>100 mL,± 20 %;
≤100 mL,± 20 mL.
>3.0 L/min,± 20 %;
≥10L/min,0.1L/min
MV
0 L/min~99 L/min
Tinsp
0.0 s ~ 3.0 s
<10L/min,0.01L/min
0.1s
≤3.0L/min,±0.6L/min.
± 15 % or 0.3s,
whichever is greater
IPAP
EPAP
0 cmH2O ~40
cmH2O
0.1cmH2O
±(2% of full scale+8%
CPAP

Waveform display:
—— airway pressure(under all modes)
Hint: The machine cannot record all the adjusting and monitoring values.
42
actual reading)

The purpose, sensor position, type and sampling method of control, measurement and display
device:
Purpose
Sensor position
Type
Sampling method
Airway pressure
inhaling end
pressure- voltage,
simulated data
Choose average value
IPAP
inhaling end
pressure- voltage,
simulated data
Choose average value
EPAP
inhaling end
pressure- voltage,
simulated data
Choose average value
CPAP
inhaling end
pressure- voltage,
simulated data
Choose average value
Frequency
internal
time and digit data
Inspiratory time
internal
time and digit data
VT
inhaling end
Flow
inhaling end
43
from multiple sampling
from multiple sampling
from multiple sampling
from multiple sampling
Choose average value
from multiple sampling
Choose average value
from multiple sampling
flow-voltage,
Choose average value
simulated data
from multiple sampling
flow- voltage,
Choose average value
simulated data
from multiple sampling
16.8 Alarm, hint and protection

Apnea alarm
Apnea time lasts for 8 s ~ 12s and no spontaneous breath, then there will be audible alarm and
visual alarm.

Disconnect alarm
Disconnect the breathing tube for 16s,then there will be audible alarm and visual alarm.

Alarm audio paused
When an alarm occurs, the alarm sound may be paused by pressing the audio paused key for 2s,
but the alarm indication will still display on the screen, unless the alarm condition disappear.
Audio paused time: ≤120 s.

Maximum pressure limit
Under normal conditions, Maximum pressure limit is less than 35cmH2O.
Under Single fault condition, Maximum pressure limit is less than 40 cmH2O.

All alarm audio will be closed by closing alarm audio function, the display“
”shows that
alarm audio is closed.
16.9 Noise

During normal operation, noise heard by patient at 1m from this machine is ≤45dB(A).
44
17 Move, storage and transportation
17.1 Move
!
△
Note:
Keep the balance and stable of the machine when move the machine. Angle of machine inclination
should be less than 10°when moving.

Before moving, all the power cable and breathing circuit pipes should be pull out from the
machine.

Don’t be toppled and collided when move the machine.
17.2 Storage

Non-invasive Ventilators shall be stored indoors with ambient temperature of - 20℃ ~ 60℃,
relative humidity of 15% ~ 95 % and atmospheric pressure at 500 hPa ~ 1060 hPa, free of
corrosive gases and not affected by strong magnetic field, and with good ventilation.
17.3 Transportation

The machine to be transported shall be packed well. Each set of machine shall be secured in its
package and soft material of adequate thickness shall be inserted in between the package and
machine to protect against movement and rubbing against each other during transportation.
The package shall be protected from damp and rain to ensure that the machine will not be
damaged in natural condition.

The packed machine can be transported by general means. The product shall be protected
from rain, damp, corrosion and against strong vibration. Turn over at handling is forbidden.

Transportation environment
Ambient temperature
-20 ℃~60 ℃
Relative humidity
15%~ 95%
Atmospheric pressure
500 hPa~1060 hPa
45
18 After-sales service commitments

For all Non-invasive Ventilators manufactured by this company, provided that user has adhered
to specification on storage, transport, and operation, our company will provide one year of
warranty (starting from the day of sales) against product quality defect resulting in failure of
normal operation, according to state stipulations. For products beyond this warranty period
(including those not in the scope of warranty), our company will still be responsible to provide
maintenance service, only charging costs of such maintenance.

The following situations are not in the scope of warranty:
——Damage or deform due to collision or falling;
—— Damage due to ingress of water or foreign matter into this machine
——Abnormal operation due to dismantling of this machine by user without approval
——Damage due to force majeure (e.g. natural disaster)

In case of fault or doubt during use, please contact the sales agent or the manufacturer.
46
2.782.062AS-A
2020.11.26
Thank you for choosing S9600 Non-invasive Ventilator.
Please read this manual before operation, and keep it for reviewing.
Manufacturer: Nanjing Superstar Medical Equipment Co., Ltd.
Address: The 2nd and 3rd Floors, No. 6 Building, No. 9 Bofu Road, Jiangbei New
Area, 211505 Nanjing, PEOPLE’S REPUBLIC OF CHINA
Post Code: 211505
Tel: 0086-25-68108300 / 0086-4001013812(service)
EXP20210521-0293
Download